NCT02719119

Brief Summary

Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

March 19, 2016

Last Update Submit

April 4, 2017

Conditions

Esophageal and Gastric Varices

Outcome Measures

Primary Outcomes (1)

  • variceal rebleeding rate

    2 years

Secondary Outcomes (5)

  • gastrointestinal rebleeding rate

    2 years

  • variceal obliteration rate

    2 years

  • number of sessions required to abstain variceal obliteration

    2 years

  • adverse events

    2 years

  • mortality

    2 years

Study Arms (2)

monthly EVL

EXPERIMENTAL

Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation monthly.

Procedure: monthly Endoscopic Variceal Ligation (EVL)

bi-weekly EVL

EXPERIMENTAL

Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation bi-weekly.

Procedure: bi-weekly Endoscopic Variceal Ligation (EVL)

Interventions

monthly Endoscopic Variceal Ligation (EVL)PROCEDURE

Patients in this group will underwent endoscopic variceal ligation monthly.

monthly EVL
bi-weekly Endoscopic Variceal Ligation (EVL)PROCEDURE

Patients in this group will underwent endoscopic variceal ligation bi-weekly.

bi-weekly EVL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute or recent bleeding from esophageal varices;
  • portal hypertension caused by cirrhosis;
  • age between 18 and 80 yr.

You may not qualify if:

  • history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
  • presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
  • presence of hepatocellular carcinoma or other malignancy;
  • an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
  • history of gastric variceal bleeding;
  • encephalopathy of stage II or worse;
  • failure to control initial variceal bleeding;
  • death within 48 h of admission;
  • refusal to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • li yang, MD

    department of gastroenterology

    STUDY CHAIR

Central Study Contacts

XUEFENG LUO, MD

CONTACT

+862885422389luo_xuefeng@yeah.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 19, 2016

First Posted

March 25, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

February 1, 2018

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

CN(1)